A worldwide experience of the management of battery failures and chronic device retrieval of the Nanostim leadless pacemaker
The result's identifiers
Result code in IS VaVaI
<a href="https://www.isvavai.cz/riv?ss=detail&h=RIV%2F00023884%3A_____%2F12%3A00007404" target="_blank" >RIV/00023884:_____/12:00007404 - isvavai.cz</a>
Result on the web
<a href="http://dx.doi.org/10.1016/j.hrthm.2017.07.004" target="_blank" >http://dx.doi.org/10.1016/j.hrthm.2017.07.004</a>
DOI - Digital Object Identifier
<a href="http://dx.doi.org/10.1016/j.hrthm.2017.07.004" target="_blank" >10.1016/j.hrthm.2017.07.004</a>
Alternative languages
Result language
angličtina
Original language name
A worldwide experience of the management of battery failures and chronic device retrieval of the Nanostim leadless pacemaker
Original language description
BACKGROUND The Nanostim leadless pacemaker (LP) met the primary endpoints in an investigational device exemption trial, and was shown to be fully retrievable percutaneously. In October 2016, St Jude Medical issued a worldwide alert of a battery malfunction that caused lost pacing output and LP communication. OBJECTIVE To report the battery failure mechanism and incidence and the worldwide patient management, including device retrieval experiences. METHODS The affected LP battery is a custom lithium-carbon monofluoride cell. These were returned after failure and underwent analysis assessing electronics and battery performance. Data were collected in ongoing clinical studies when LPs were abandoned or retrieved. RESULTS Of 1423 LPs implanted worldwide, there were 34 battery failures, occurring at 2.9 +/- 0.4 years with no instances of associated patient injury. Analysis of returned batteries revealed an increase in battery resistance caused by insufficient electrolyte availability at the cathode/anode interface. A total of 66 of 73 retrieval attempts were successful (90.4%; implant duration range: 0.2-4.0 years). The LP docking button was inaccessible in 6 patients, and the docking button detached from the LP during retrieval in 1 patient. There was 1 case of arteriovenous fistula and another case of the LP docking button migrating into the pulmonary artery. There were also 115 non-LP retrieval patients after the advisory who received an additional pacemaker, with no adverse device-to-device interactions reported. CONCLUSION As with standard pacers, LPs can have critical battery failures. Chronic retrieval of LPs is safe and efficacious.
Czech name
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Czech description
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Classification
Type
J<sub>imp</sub> - Article in a specialist periodical, which is included in the Web of Science database
CEP classification
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OECD FORD branch
30201 - Cardiac and Cardiovascular systems
Result continuities
Project
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Continuities
N - Vyzkumna aktivita podporovana z neverejnych zdroju
Others
Publication year
2017
Confidentiality
S - Úplné a pravdivé údaje o projektu nepodléhají ochraně podle zvláštních právních předpisů
Data specific for result type
Name of the periodical
Heart Rhythm
ISSN
1547-5271
e-ISSN
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Volume of the periodical
14
Issue of the periodical within the volume
12
Country of publishing house
US - UNITED STATES
Number of pages
8
Pages from-to
1756-1763
UT code for WoS article
000417131600006
EID of the result in the Scopus database
2-s2.0-85027231508